CurrentEmblemHealthPolicy N/A

Prior Authorization Criteria — Pharmacy & Specialty Drugs (Medicare PA List)

Customize your policy alerts

Sign up for all EmblemHealth policy alerts

Know when EmblemHealth releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This document lists drugs requiring prior authorization for EmblemHealth Medicare HMO/PPO plans and specifies requirements providers must meet for approval, including medications that may be covered under Medicare Part B or D depending on use and administration.

Policy Summary

PayerEmblemHealth

PolicyPrior Authorization Criteria — Pharmacy & Specialty Drugs (Medicare PA List)

Policy CodePolicy N/A

Change TypeAdministrative update (no material clinical changes)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionProviders must obtain prior authorization and supply required documentation (diagnosis, supporting labs or treatment history) before prescribing listed drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15+document parts in this partial extract

12 mostandard approval duration (examples)

4+Aimovig initial threshold

FDA contraindicationscommon exclusion

MultiplePA group examples in excerpt

Coverage Criteria and Drug-Specific Rules

Group approval criteria

Covered when ALL of the following are met

Indication and dosing: Patient has an FDA labeled indication or an indication supported in CMS‑approved compendia for the requested agent AND the requested dose is within FDA labeled dosing or supported in CMS‑approved compendia dosing for the requested indication

Applies to the prior authorization group described in this extract.

Coverage duration: Approval will be for 12 months12 months

Renewal requirements not detailed in this extract

Aimovig - Initial Therapy

Covered when ALL of the following are met

Aimovig initial approval: 1. Patient has a diagnosis of migraine; 2. The requested agent is being used for migraine prophylaxis; 3. Patient has 4 or more migraine headache days per month; 4. Patient will NOT be using the requested agent in combination with another calcitonin gene‑related peptide (CGRP) agent for migraine prophylaxis4+ migraine days/month

Approval duration: 12 months

Aimovig - Renewal

Renewal covered when ALL of the following are met

Aimovig renewal: 1. Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria; 2. Patient has a diagnosis of migraine; 3. The requested agent is being used for migraine prophylaxis; 4. Patient has had clinical benefit with the requested agent; 5. Patient will NOT be using the requested agent in combination with another CGRP agent for migraine prophylaxisclinical benefit documented

Approval duration: 12 months

Alcohol Swabs - Initial Therapy

Covered when BOTH of the following are met

Alcohol Swabs approval: 1. The requested medical supply product will be used in the delivery of insulin to the body; 2. Patient's medication history includes use of insulin within the past 180 daysinsulin use within 180 days

Approval duration: 12 months

Alosetron - Initial Therapy

Covered when ALL of the following are met (and no FDA contraindication exists)

Alosetron approval: 1. Patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS‑D); 2. Patient's sex is female; 3. Patient exhibits at least ONE of: frequent and severe abdominal pain/discomfort OR frequent bowel urgency or fecal incontinence OR disability or restriction of daily activities due to IBS; 4. Prescriber has ruled out anatomic or biochemical abnormalities of the gastrointestinal tractat least one listed severe symptom

Exclude if any FDA‑labeled contraindications to alosetron present; approval duration: 12 months

Miscellaneous PA Groups — Covered when criteria per group are met

Covered when criteria per group are met

Acyclovir Topical: Indications: All Medically‑Accepted Indications (see group entry for required medical information)N/A

PA group described

Other listed PA groups: Several PA groups list 'All FDA‑Approved Indications' or 'All Medically‑Accepted Indications'; providers must supply the specific required medical information per group entryN/A

See individual group entries for details

Initial Therapy — Prolastin‑C (Alpha‑1 proteinase inhibitor)

Prolastin‑C (Alpha‑1 proteinase inhibitor) — Initial approval

Prolastin‑C initial approval: 1. Patient has a diagnosis of alpha‑1 antitrypsin deficiency (AATD) with clinically evident emphysema; 2. Patient has a pre‑treatment serum AAT level less than 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry); 3. The requested dose is within FDA‑labeled dosing for the requested indicationAAT < 11 micromol/L

All conditions required

Continuation Therapy — Prolastin‑C renewal

Prolastin‑C — Renewal

Prolastin‑C renewal: 1. Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria; 2. Patient has a diagnosis of AATD with clinically evident emphysema; 3. Patient has had clinical benefit with the requested agent; 4. The requested dose is within FDA‑labeled dosing for the requested indication

All conditions required

Initial Therapy — Danazol approval criteria

Danazol — Approval criteria

Danazol approval: 1. Patient has ONE of: an FDA‑labeled indication OR an indication supported in CMS‑approved compendia for the requested agent; AND 2. ONE of: patient will NOT be using the requested agent in combination with another androgen or anabolic steroid OR prescriber has provided justification for combination therapy

Both bullet groups required

Initial Therapy — Testosterone cypionate/enanthate approval criteria

Testosterone cypionate/enanthate — Approval criteria

Testosterone approval: 1. Patient has ONE of the specified diagnoses: A) male with AIDS/HIV‑associated wasting syndrome meeting objective weight/BMI/BCM criteria and other causes ruled out; B) female with metastatic/inoperable breast cancer; C) male with primary or secondary (hypogonadotropic) hypogonadism; D) male adolescent with delayed puberty; AND 2. If male, ONE of: pretreatment total or free serum testosterone below lab lower limit or <300 ng/dL, OR on therapy with monitoring levels as described; AND 3. ONE of: patient will NOT be using the requested agent in combination with another androgen/anabolic steroid OR prescriber provides justification for combination usetestosterone lab thresholds as specified

All groups required; within this, several OR conditions define acceptable diagnoses and lab findings; approval duration: 6 months for delayed puberty, 12 months for other indications

Armodafinil Initial Approval

Armodafinil Initial Approval — requires BOTH of the following

Armodafinil initial approval: 1. Patient has an FDA labeled indication or an indication supported in CMS‑approved compendia for the requested agent; 2. Patient will NOT be using the requested agent in combination with another target agent (e.g., modafinil)

Eucrisa Initial Approval

Eucrisa Initial Approval — requires BOTH of the following

Eucrisa initial approval: 1. Patient has a diagnosis of atopic dermatitis; AND 2. ONE of: A) patient has tried and had an inadequate response to a topical corticosteroid or combination preparation; B) patient has an intolerance or hypersensitivity to a topical corticosteroid or combination preparation; C) patient has an FDA‑labeled contraindication to a topical corticosteroid or combination preparation

Tacrolimus Initial Approval

Tacrolimus Initial Approval — topical tacrolimus requires ONE of the following

Tacrolimus initial approval: 1. Patient has a diagnosis of atopic dermatitis AND ONE of: A) prior inadequate response to a topical corticosteroid or combination preparation; B) intolerance or hypersensitivity to a topical corticosteroid or combination preparation; C) FDA‑labeled contraindication to a topical corticosteroid or combination preparation; OR 2. Patient has an indication supported in CMS‑approved compendia for the requested agent

Approval duration: 12 months

Atovaquone Approval Criteria

Atovaquone Approval Criteria — requires ONE of the following structures

Atovaquone approval option A: A. BOTH: i) ONE of: patient has mild‑to‑moderate Pneumocystis jirovecii pneumonia OR patient is using the agent for prevention of Pneumocystis jirovecii pneumonia; AND ii) ONE of: patient has intolerance or hypersensitivity to TMP/SMX OR patient has an FDA‑labeled contraindication to TMP/SMX

Atovaquone approval option B: B. Patient has an indication that is supported in CMS‑approved compendia for the requested agent

Approval duration: 12 months

Attruby Initial Approval

Attruby Initial Approval — requires ALL of the following

Attruby initial approval: 1. Patient has a diagnosis of cardiomyopathy of wild type or variant transthyretin‑mediated amyloidosis (ATTR‑CM); 2. Diagnosis confirmed by testing (e.g., PYP scanning, monoclonal antibody studies, biopsy, scintigraphy, genetic testing); 3. Requested agent will be used to reduce cardiovascular death and cardiovascular‑related hospitalization; 4. NYHA Functional Class I, II, or III heart failure; 5. Clinical manifestations of cardiomyopathy (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema); 6. Patient will NOT be using the requested agent in combination with Amvuttra or a tafamidis agent for the requested indication

Prescriber is a specialist or has consulted one (see group entry)

Attruby Renewal Approval

Attruby Renewal Approval — requires ALL of the following

Attruby renewal approval: 1. Patient has been previously approved through the plan's Prior Authorization criteria; 2. Patient has a diagnosis of ATTR‑CM; 3. Requested agent is used to reduce cardiovascular death and cardiovascular‑related hospitalization; 4. NYHA Functional Class I, II, or III; 5. Patient has had clinical benefit with the requested agent; 6. Patient will NOT be using the requested agent in combination with Amvuttra or a tafamidis agent for the requested indication

All conditions required

Austedo — Criteria for approval

Austedo — Criteria for approval require ALL of the following

Austedo approval: 1. ONE of: A) patient has chorea associated with Huntington's disease AND BOTH: i) either no current diagnosis of depression OR current depression is being treated; and ii) either no passive suicidal ideation/behavior OR passive suicidal ideation/behavior with patient not actively suicidal; OR B) patient has tardive dyskinesia AND ONE: prescriber reduced/discontinued medications known to cause tardive dyskinesia OR prescriber provided rationale why reduction/discontinuation is not appropriate; AND 2. Patient will NOT be using the requested agent in combination with an MAOI; AND 3. Patient will NOT be using the requested agent in combination with reserpine

Approval duration: 12 months

Tadalafil (BPH) — Criteria

Tadalafil (BPH) — Criteria require BOTH of the following

Tadalafil for BPH: 1. Patient has a diagnosis of benign prostatic hyperplasia (BPH); 2. Patient has tried and had an insufficient response, intolerance, hypersensitivity, or FDA‑labeled contraindication to TWO alpha blocker agents (e.g., terazosin, doxazosin, tamsulosin)

Exclusion: requests to treat erectile dysfunction only are not covered

Benlysta SC (initial and renewal)

Benlysta SC (initial and renewal) — initial criteria require BOTH of the following

Benlysta SC indication: ONE of: a) active systemic lupus erythematosus (SLE) with continuation of standard SLE therapy (corticosteroids, hydroxychloroquine, immunosuppressives); OR b) active lupus nephritis (LN) with continuation of standard LN therapy (corticosteroids, immunosuppressives)

Age >= 5 years for these indications

Benlysta concomitant therapy: Patient will NOT be using the requested agent in combination with another biologic agent

For renewal, patient must have had clinical benefit and prior approval

Clobazam

Clobazam — Criteria for approval (note PA exemption under age 65 described elsewhere)

Exemption: PA does NOT apply to patients less than 65 years of age<65 years

If PA applies (patient >=65), require either evidence of current treatment within past 180 days or prescriber attestation AND an FDA labeled indication or CMS compendia‑supported indication; alternatively diagnosis‑based pathways with no FDA contraindications

Option A: BOTH: (i) evidence of a claim showing current treatment within past 180 days OR prescriber states patient is currently being treated with the requested agent; AND (ii) patient has an FDA labeled indication or an indication supported in CMS‑approved compendia

Option B: BOTH: (i) patient has ONE of: seizure disorder OR an indication supported in CMS compendia; AND (ii) patient does NOT have any FDA‑labeled contraindications to the requested agent

General approval criteria (excerpt)

General approval criteria (excerpt) — Approval requires ONE of the following

Option A (ongoing therapy): BOTH: (i) evidence of a claim showing the patient is currently treated with the requested agent within the past lookback period (90–180 days) OR prescriber states the patient is currently being treated with the requested agent; AND (ii) patient has an FDA labeled indication or an indication supported in CMS‑approved compendia

Prescriber attestation acceptable when claim evidence absent

Option B (diagnosis pathway): BOTH: (i) patient has one of the listed diagnoses (e.g., seizure disorder, anxiety with required prior SSRI/SNRI trial or intolerance, alcohol withdrawal, or other compendia‑supported indications); AND (ii) patient does NOT have any FDA‑labeled contraindications to the requested agent

Used across benzodiazepine group entries

Clorazepate-specific criteria (Option B diagnoses)

Clorazepate Option B (expanded): BOTH: (i) patient has ONE of: seizure disorder OR anxiety disorder AND one of: trial and inadequate response to a formulary SSRI/SNRI OR intolerance/hypersensitivity to a formulary SSRI/SNRI OR FDA labeled contraindication to a formulary SSRI/SNRI, OR alcohol withdrawal, OR an indication supported in CMS compendia; AND (ii) patient does NOT have any FDA labeled contraindications to the requested agent

PA does NOT apply to patients <65 years where stated

Diazepam-specific criteria (Option B diagnoses)

Diazepam Option B (expanded): BOTH: (i) patient has ONE of: seizure disorder OR anxiety disorder AND one of: trial and inadequate response to a formulary SSRI/SNRI OR intolerance/hypersensitivity to a formulary SSRI/SNRI OR FDA labeled contraindication to a formulary SSRI/SNRI, OR skeletal muscle spasms, OR alcohol withdrawal, OR an indication supported in CMS compendia; AND (ii) patient does NOT have any FDA labeled contraindications to the requested agent

PA does NOT apply to patients <65 years where stated

Lorazepam criteria (excerpt)

Lorazepam criteria (excerpt) — follows general approval structure

Lorazepam criteria: BOTH: (i) evidence of claim of current treatment within past 180 days OR prescriber statement of current treatment; and (ii) patient has an FDA labeled indication or an indication supported in CMS compendia for the requested agent

PA does NOT apply to patients less than 65 years of age where stated

Benzodiazepines PA — approval criteria

Benzodiazepines PA — approval criteria require ONE of the following

Initial approval pathways: Option A: BOTH: (i) evidence of a claim showing current treatment within past 180 days OR prescriber states current treatment; AND (ii) patient has an FDA labeled indication or an indication supported in CMS compendia. Option B: BOTH: (i) patient has one of listed diagnoses (e.g., anxiety disorder with prior SSRI/SNRI trial/intolerance/contraindication, seizure disorder, alcohol withdrawal, or compendia‑supported indication); AND (ii) patient has no FDA‑labeled contraindications to the requested agent

Prescriber attestation or claim evidence acceptable for ongoing therapy; contraindication exclusion applies.

Sympazan — approval criteria

Sympazan — approval criteria require ONE of the following

Sympazan approval pathways: Option A: BOTH: (i) evidence of a claim showing current treatment within past 180 days OR prescriber attestation of current treatment; AND (ii) patient has an FDA labeled indication or an indication supported in CMS compendia. Option B: BOTH: (i) patient has diagnosis of seizure disorder OR a compendia‑supported indication; AND (ii) patient has no FDA‑labeled contraindications to the requested agent

PA does NOT apply to patients less than 65 years of age where stated

Bexarotene gel — initial and renewal criteria

Bexarotene gel initial approval: 1. Patient has an FDA labeled indication or an indication supported in CMS‑approved compendia; AND 2. ONE of: evidence of claim of current treatment within past 180 days; prescriber states current treatment; OR pathway C (stage IA/IB CTCL with refractory/persistent disease despite prior skin‑directed therapy, intolerance, or contraindication, specialist involvement, and no FDA contraindications)

Specialist involvement required for pathway C; approval duration: 12 months

Bexarotene gel renewal approval: 1. Previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication or compendia‑supported indication; AND 3. ONE of: evidence of claim of current treatment within past 180 days; prescriber states current treatment; OR patient has had clinical benefit with the agent AND prescriber is a specialist or has consulted one AND no FDA contraindications

Clinical benefit required on renewal if not evidenced by claims/attestation

Actemra — initial and renewal criteria

Actemra — initial and renewal criteria (Biologic immunomodulators group)

Actemra initial approval: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim of current treatment within past 90 days OR prescriber states current treatment and provides clinical justification that patient is at risk if therapy changed OR patient's diagnosis is indicated for preferred biologic(s) AND one of: medication history shows use of preferred biologic(s) OR intolerance/hypersensitivity to preferred biologic(s) OR FDA labeled contraindication to preferred biologic(s) OR request is for an FDA labeled indication not covered by preferred biologic(s); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Lookback 90 days; combination biologic use excluded

Actemra renewal approval: 1. Previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity/frequency); AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Clinical improvement required on renewal

Initial Therapy (general biologic immunomodulator block)

Initial Therapy — General biologic immunomodulator initial criteria

Initial approval general criteria: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: A) evidence of a claim showing current treatment within the past 90 days; B) prescriber states current treatment and provides clinical justification that patient is at risk if therapy is changed; C) patient's diagnosis is indicated for preferred biologic(s) AND one of: medication history shows use of preferred biologic(s) OR intolerance/hypersensitivity to preferred biologic(s) OR FDA labeled contraindication to preferred biologic(s); OR D) request is for an FDA labeled indication not covered by preferred biologic(s); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Reflects branch logic with nested ORs

Continuation / Renewal Therapy — General biologic immunomodulators

Covered when ALL of the following are met for renewal

Renewal criteria (biologics): 1. Patient has been previously approved through the plan's PA criteria; AND 2. Patient has an FDA labeled indication for the requested agent; AND 3. Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity and/or frequency); AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Applies to multiple biologic agent sections

Entyvio SC Initial Therapy

Entyvio SC Initial Therapy — Covered when BOTH of the following are met

Entyvio SC initial criteria: 1. Patient has an FDA labeled indication for the requested agent; AND 2. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Approval duration: 12 months

Hadlima — Initial and Renewal

Hadlima initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Initial approval requires both conditions

Hadlima renewal: 1. Patient has been previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement; AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Renewal requires all conditions

Orencia — Initial and Renewal (and general conventional prerequisites)

Orencia initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim of current treatment within past 90 days; prescriber states current treatment with clinical justification; patient's medication history indicates use of another biologic for same indication; diagnosis does NOT require a conventional prerequisite agent; patient's medication history shows use of ONE formulary conventional prerequisite agent; intolerance/hypersensitivity to at least ONE formulary conventional prerequisite agent; OR FDA‑labeled contraindication to at least ONE formulary conventional prerequisite agent; AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Conventional prerequisite rules apply for plaque psoriasis, RA, JIA per group guidance

Orencia renewal: 1. Previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement; AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Conventional prerequisite rules: Use of ONE conventional prerequisite agent is required for plaque psoriasis, rheumatoid arthritis, or juvenile idiopathic arthritis; no prerequisites required for listed other diagnoses

Formulary conventional agents listed in group guidance

Pyzchiva — Initial and Renewal

Pyzchiva initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim showing current treatment within past 90 days; prescriber states current treatment with clinical justification; medication history indicates use of another biologic for the same indication; diagnosis does NOT require a conventional prerequisite agent; medication history indicates use of ONE formulary conventional prerequisite agent; intolerance/hypersensitivity to at least ONE formulary conventional prerequisite agent; OR FDA labeled contraindication to at least ONE formulary conventional prerequisite agent; AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Pyzchiva renewal: 1. Previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement; AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Rinvoq Solution Criteria

Rinvoq Solution — Initial and renewal criteria

Rinvoq Solution initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of the listed evidence/prerequisite options is met (e.g., claim within 90 days; prescriber attestation with justification; medication history shows prior biologic use for same indication; diagnosis not requiring conventional prerequisite; prior use of one formulary conventional agent; intolerance to conventional agent; FDA contraindication to conventional agent); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

ONE of multiple options must be met

Rinvoq Solution renewal: 1. Previously approved through plan PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement; AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Rinvoq Lq Criteria

Rinvoq Lq — Initial and renewal criteria and other conditions

Rinvoq Lq initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim within past 90 days; prescriber attestation with clinical justification; patient's medication history indicates use of preferred TNF agent(s); intolerance/hypersensitivity to preferred TNF agent(s); FDA labeled contraindication to preferred TNF agent(s); OR request is for indication not covered by preferred TNF agent(s); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Preferred TNF options described; approval duration: 12 months

Rinvoq Lq renewal: Previously approved through plan criteria; AND FDA labeled indication; AND clinical improvement; AND not used in combination with another biologic immunomodulator

Rinvoq Tablet Criteria

Rinvoq Tablet — Initial and renewal criteria and diagnosis‑specific prerequisites

Rinvoq Tablet initial (general): 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim within past 90 days; prescriber attestation with justification; OR complex branch per diagnosis (see complex branch); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Complex branch includes preferred TNF or conventional prerequisite rules

Complex branch details: i. For indications other than moderate to severe atopic dermatitis: medication history indicates use of preferred TNF agent(s) OR intolerance to preferred TNF OR FDA contraindication to preferred TNF OR request is for indication not covered by preferred TNF; OR ii. For moderate to severe atopic dermatitis: medication history indicates use of TWO conventional prerequisite agents (one formulary topical corticosteroid AND one formulary topical calcineurin inhibitor) OR intolerance to TWO conventional prerequisite agents OR FDA contraindication to TWO conventional prerequisite agents

Rinvoq Tablet renewal: Previously approved through plan criteria; AND FDA labeled indication; AND clinical improvement; AND not used in combination with another biologic immunomodulator

Additional diagnosis‑specific prerequisite rules apply

Initial Approval — General biologic immunomodulators

Initial Approval — Covered when ALL of the following are met for initial approval (general biologic block)

Initial Approval - General: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of A–G is met: A) evidence of a claim showing treatment within past 90 days; B) prescriber attestation of current treatment with clinical justification; C) medication history indicates use of another biologic immunomodulator for same indication; D) diagnosis does not require a conventional prerequisite agent; E) medication history indicates use of ONE formulary conventional prerequisite agent; F) intolerance/hypersensitivity to at least ONE formulary conventional prerequisite agent; G) FDA labeled contraindication to at least ONE formulary conventional prerequisite agent; AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Applies to multiple named biologics

Renewal Approval — General biologic immunomodulators

Renewal Approval — Covered when ALL of the following are met for renewal

Renewal Approval: 1. Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria; AND 2. Patient has an FDA labeled indication for the requested agent; AND 3. Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity/frequency); AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Standard renewal criteria across listed agents

Diagnosis-specific prerequisites

Diagnosis‑specific prerequisites — Additional criteria by diagnosis

Diagnosis-specific prerequisites: - Use of ONE preferred TNF (Hadlima or Simlandi) is required for ankylosing spondylitis, rheumatoid arthritis, adult psoriatic arthritis, or juvenile idiopathic arthritis. - Use of TWO conventional prerequisite agents is required for moderate to severe atopic dermatitis. - Use of ONE conventional prerequisite agent is required for plaque psoriasis (formulary conventional agents listed). - NO preferred TNF agents are required for certain diagnoses (pediatric psoriatic arthritis, non‑radiographic axial spondyloarthritis, giant cell arteritis, moderate/severe Crohn's disease, moderate/severe ulcerative colitis).

See group entries for formulary conventional agents and details

Initial Therapy — Named biologics

Initial Therapy — Covered when ALL of the following are met (named biologics block)

Initial approval (named biologics): 1. Patient has an FDA labeled indication for the requested agent

(Required)

Supporting evidence (one required): One of the following must be met: evidence of claim showing current treatment within past 90 days; prescriber states current treatment and provides clinical justification that patient is at risk if therapy changed; patient's medication history shows use of another biologic immunomodulator for same indication; patient's diagnosis does not require a conventional prerequisite agent; patient's medication history shows use of one formulary conventional prerequisite agent for the requested indication; patient intolerant/hypersensitive to at least one formulary conventional prerequisite agent; patient has an FDA labeled contraindication to at least one formulary conventional prerequisite agent.1 of 7

(Choose one)

Combination therapy exclusion: Patient will NOT be using the requested agent in combination with another biologic immunomodulator

(Required)

Continuation / Renewal Therapy — Named biologics

Continuation / Renewal Therapy — Renewal approval requires ALL of the following

Prior approval history: Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria

(Required)

Ongoing indication: Patient has an FDA labeled indication for the requested agent

(Required)

Clinical improvement: Patient has had clinical improvement defined as slowing of disease progression or decrease in symptom severity and/or frequency

(Required)

Combination therapy exclusion: Patient will NOT be using the requested agent in combination with another biologic immunomodulator

(Required)

Initial approval — Biologic immunomodulators (Tyenne)

Initial approval (Tyenne): 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of a claim showing current treatment within the past 90 days; prescriber attests current treatment with clinical justification that patient is at risk if therapy changed; OR patient's diagnosis is indicated for preferred biologic(s) AND one of: medication history shows use of preferred biologic(s) OR intolerance/hypersensitivity to preferred biologic(s) OR FDA labeled contraindication to preferred biologic(s); OR request is for an FDA labeled indication not covered by preferred biologic(s); AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Applies to Tyenne and similar agents

Renewal approval — Biologic immunomodulators (Tyenne)

Renewal requirements (Tyenne): 1. Patient has been previously approved through the plan's PA criteria; AND 2. Patient has an FDA labeled indication for the requested agent; AND 3. Patient has had clinical improvement; AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Standard renewal criteria

Carglumic acid — Approval criteria

Carglumic acid — Approval criteria require BOTH of the following

Carglumic approval: 1. Patient has a diagnosis of ONE of: acute hyperammonemia due to NAGS deficiency OR chronic hyperammonemia due to NAGS deficiency OR acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA); AND 2. The requested dose is within FDA‑labeled dosing for the requested indication

All conditions required

Cayston — Approval criteria

Cayston — Approval criteria require ALL of the following (CF + Pseudomonas)

Cayston approval: 1. Patient has a diagnosis of cystic fibrosis; AND 2. Documentation indicates the patient has a Pseudomonas aeruginosa respiratory infection; AND 3. ONE of: patient is NOT currently (within past 60 days) being treated with another inhaled antibiotic OR patient is currently treated with another inhaled antibiotic AND either prescriber confirms other inhaled antibiotic will be discontinued and therapy continued only with requested agent OR prescriber supports concurrent/alternating therapy with the requested agent

Approval duration: 12 months

Chenodal — Approval criteria

Chenodal — Approval criteria require BOTH of the following

Chenodal approval: 1. Patient has a diagnosis of radiolucent stones in a well‑opacifying gallbladder; AND 2. The requested dose is within FDA‑labeled dosing for the requested indication

Approval duration: 12 months

Chorionic Gonadotropin — Initial Approval

Chorionic Gonadotropin — Initial Approval — Covered when ONE of the following is met

Chorionic Gonadotropin approval options: A. Patient has a diagnosis of prepubertal cryptorchidism not due to anatomic obstruction; OR B. Male with hypogonadotropic hypogonadism AND BOTH: i) total or free testosterone below lab lower limit or <300 ng/dL; AND ii) LH and FSH at low‑normal or below lab range; OR C. Patient has an indication supported in CMS‑approved compendiasee children

Approval duration: 12 months

Cinacalcet — Initial Approval

Cinacalcet — Initial Approval — Covered when ONE of the following is met

Cinacalcet approval options: A. Hypercalcemia due to parathyroid carcinoma; OR B. Primary hyperparathyroidism with pretreatment serum calcium above laboratory upper limit AND patient unable to undergo parathyroidectomy; OR C. Another FDA‑approved indication or indication supported in CMS‑approved compendia not excluded from Part D

Approval duration: 12 months

Cobenfy — Initial and Renewal Approval

Cobenfy — Initial and Renewal Approval — initial requires BOTH of the following

Cobenfy initial: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of claim within past 180 days showing current treatment; prescriber states current treatment; OR ALL of: baseline liver enzymes and bilirubin assessed, baseline heart rate assessed, AND one of: trial and inadequate response to two antipsychotics OR intolerance to two antipsychotics OR FDA‑labeled contraindication to two antipsychotics; AND patient does NOT have any FDA‑labeled contraindications to Cobenfy

Approval duration: 12 months

Cobenfy renewal: 1. Previously approved through plan PA criteria; AND 2. FDA labeled indication; AND 3. ONE of: evidence of claim in past 180 days OR prescriber states current treatment OR ALL of: appropriate monitoring performed (liver enzymes/bilirubin, heart rate), no FDA contraindications; AND 4. Patient has had clinical benefit with the requested agent

Renewal requires documentation of benefit

Granix — Approval

Granix criteria: Patient has an FDA labeled indication or an indication supported in CMS‑approved compendia; AND prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist

Approval duration: 12 months

Off‑label uses: the policy lists an Off‑Label Uses: Exclusion Criteria heading. Where off‑label use is considered, approval requires both an FDA‑labeled indication or an indication supported in CMS‑approved compendia and that the requested dose is within FDA‑labeled dosing or CMS‑compendia‑supported dosing for the requested indication.

Alosetron: the policy explicitly states that FDA‑labeled contraindications to the requested agent are exclusion criteria. For Alosetron specifically, approval is contingent on meeting the listed clinical criteria and no FDA‑labeled contraindication being present.

FDA‑labeled contraindications: multiple PA group entries note that any FDA‑labeled contraindication to the requested agent is an exclusion to coverage. Requests meeting an agent's FDA contraindication will be excluded or denied.

Concomitant‑use exclusions: certain agents are prohibited from being used with specified other therapies. For example, armodafinil must NOT be used in combination with modafinil, and Attruby must NOT be used in combination with Amvuttra or a tafamidis agent for the same indication. Providers must follow these combination restrictions when requesting PA.

Key Clinical Thresholds and Coding Values

inv-69: Migraine headache days per month — >= 4

Threshold>= 4 migraine headache days per month

ContextApplies to Aimovig initial approval for migraine prophylaxis

Renewal noteRenewal requires documented clinical benefit and prior plan approval

inv-70: Pre‑treatment serum alpha‑1 antitrypsin (AAT) — < 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry)

ThresholdPre‑treatment serum AAT < 11 micromol/L

Equivalent measurements80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry

ContextRequired for Prolastin‑C initial approval in patients with AATD and clinically evident emphysema

inv-71: Total serum testosterone (male pretreatment) — below lab LLN or < 300 ng/dL

ThresholdTotal serum testosterone below the testing laboratory's lower limit of normal or < 300 ng/dL

Applies toMale patients as pretreatment criterion for testosterone injectable approval

Combination therapyApproval requires not using with another androgen/anabolic steroid unless prescriber justifies

inv-72: Total serum testosterone (duplicate listing) — below laboratory lower limit of normal or < 300 ng/dL

ThresholdTotal serum testosterone below the testing laboratory's lower limit of normal or < 300 ng/dL

ContextAcceptable as measured current or pretreatment total serum testosterone for hypogonadotropic hypogonadism pathway

AlternativeFree serum testosterone below the testing laboratory's lower limit of normal also acceptable

inv-73: LH and FSH — at (low‑normal) or below laboratory normal range (hypogonadotropic hypogonadism)

Required findingLH and FSH at low‑normal or below the testing laboratory's normal range

ContextNeeded to establish hypogonadotropic hypogonadism for chorionic gonadotropin PA pathway

Associated testosterone requirementMust accompany low total or free testosterone per lab LLN or <300 ng/dL

inv-74: Pretreatment serum calcium — above laboratory upper limit of normal (Cinacalcet context)

ThresholdPretreatment serum calcium above the testing laboratory's upper limit of normal

ContextRequired for cinacalcet approval in primary hyperparathyroidism pathway when surgery not possible

IndicationsAlso applies to hypercalcemia due to parathyroid carcinoma per criteria

inv-75: Prior authorization — definition (callout/listed here for cross-reference)

DefinitionPrior authorization: payer approval obtained by the prescriber before prescribing a listed drug to ensure coverage

RequirementProvider must contact EmblemHealth and supply information describing use and administration of the drug for coverage determination

Default approval durationApproval will generally be for 12 months when criteria are met

Prior Authorization Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior authorization: FDA or compendia indication + dosing within label

Approval requires BOTH: (1) patient has an FDA‑labeled indication OR an indication supported in CMS‑approved compendia for the requested agent, AND (2) the requested dose is within FDA‑labeled dosing or dosing supported in CMS‑approved compendia. Approval duration: 12 months.

Prior Authorization

PA required for listed groups (examples)

Prior authorization is required for the listed PA groups; providers must obtain PA for the named groups (examples include topical acyclovir, Aimovig, alcohol swabs, alosetron, and the Alpha‑1‑Proteinase Inhibitor group such as Prolastin‑C).

Acyclovir Topical (Acyclovir) [[18]]
Aimovig [[22]]
Alcohol Swabs [[26]]
Alosetron Hcl [[30]]
Alpha‑1‑Proteinase Inhibitor — Prolastin‑C [[37]]

Prior Authorization

Aimovig prior authorization criteria

Initial approval requires ALL: diagnosis of migraine, use for migraine prophylaxis, ≥4 migraine headache days per month, and the agent will NOT be used concomitantly with another CGRP prophylactic agent. Renewal requires prior plan approval, continued diagnosis, clinical benefit, and no combination CGRP use.

Initial: migraine diagnosis; prophylactic use; ≥4 migraine days/month; no concurrent CGRP agent
Renewal: previously approved, migraine diagnosis, clinical benefit, no concurrent CGRP agent

Prior Authorization

Alcohol swabs PA: used for insulin delivery + recent insulin use

Approval requires BOTH: the alcohol swab product will be used in delivery of insulin to the body, AND the patient's medication history documents insulin use within the past 180 days.

Use in insulin delivery required
Insulin use documented within past 180 days

Prior Authorization

Alosetron PA: required patient characteristics and symptom severity

Alosetron approval requires ALL: diagnosis of IBS‑D; patient is female; patient exhibits at least one severe symptom (frequent severe abdominal pain/discomfort, frequent bowel urgency/fecal incontinence, or disability/restriction of daily activities due to IBS); and prescriber has ruled out anatomic or biochemical GI abnormalities. Exclude if FDA‑labeled contraindications exist.

IBS‑D diagnosis
Female sex
At least one listed severe symptom
Anatomic/biochemical GI abnormalities ruled out
Exclude if FDA‑labeled contraindications present

Prior Authorization

Off‑label/compendia requirement for initial approval

When off‑label use is being considered, initial approval requires the patient have an FDA‑labeled indication OR an indication supported in CMS‑approved compendia.

Prior Authorization

Prolastin‑C PA and 12‑month approval when criteria met

Prolastin‑C requires prior authorization under the Alpha‑1‑Proteinase Inhibitor PA group. Initial approval requires AATD with clinically evident emphysema, pre‑treatment AAT < 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry), and dosing within FDA‑labeled dosing. Approval duration: 12 months when criteria met.

Pre‑treatment AAT < 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry) [[40]]

Prior Authorization

Danazol PA: Anabolic Steroid group; 12‑month approval

Danazol requires prior authorization under the Anabolic Steroid PA group. Approval requires an FDA‑labeled indication or CMS compendia support and either no concurrent use with another androgen/anabolic steroid or prescriber justification for combination use; approval duration: 12 months.

Must have FDA indication or CMS compendia support
Either not used with another androgen/anabolic steroid OR prescriber provides justification

Prior Authorization

Testosterone injectable PA: prescriber documentation and lab requirements

Testosterone injectable formulations (cypionate, enanthate) require prior authorization under the Androgen Injectable PA groups. Providers must document the applicable diagnosis and, for males, pretreatment or monitoring testosterone levels per policy; approval is 6 months for delayed puberty and 12 months for other indications.

Document diagnosis per listed acceptable diagnoses (e.g., hypogonadism, AIDS wasting, adolescent delayed puberty) [[52]]
For males, provide pretreatment or current total/free testosterone levels per policy [[52]]
Duration: 6 months for delayed puberty; 12 months for other indications [[53]]

Prior Authorization

Armodafinil PA: indication/compendia + no concomitant modafinil

Armodafinil requires prior authorization; approval requires an FDA‑labeled indication or CMS‑compendia support AND the agent will NOT be used in combination with another target agent (i.e., modafinil).

Must not be used concomitantly with modafinil

Prior Authorization

Eucrisa PA: prior trial of topical corticosteroid or documented intolerance required

Eucrisa requires prior authorization; approval requires a diagnosis of atopic dermatitis AND either prior inadequate response to a topical corticosteroid, intolerance/hypersensitivity to a topical corticosteroid, or an FDA‑labeled contraindication to topical corticosteroids.

Diagnosis of atopic dermatitis
One of: prior inadequate response to topical corticosteroid; intolerance/hypersensitivity; or FDA contraindication to topical corticosteroid

Prior Authorization

Topical tacrolimus PA: prior corticosteroid trial or documented intolerance/compendia alternative

Topical tacrolimus requires prior authorization; approval requires either: (a) atopic dermatitis diagnosis PLUS prior inadequate response to a topical corticosteroid, intolerance/hypersensitivity to a topical corticosteroid, or FDA‑labeled contraindication to topical corticosteroid; OR (b) an indication supported in CMS‑approved compendia.

Atopic dermatitis diagnosis plus one of: prior inadequate response to topical corticosteroid; intolerance/hypersensitivity; or FDA contraindication
Or a CMS compendia‑supported indication

Prior Authorization

Atovaquone PA: PJP diagnosis and TMP‑SMX intolerance OR compendia‑supported indication

Atovaquone requires prior authorization; approval requires ONE of: (A) diagnosis of mild‑to‑moderate Pneumocystis jirovecii pneumonia or use for prevention AND documented intolerance/hypersensitivity or FDA‑labeled contraindication to TMP‑SMX; OR (B) an indication supported in CMS‑approved compendia.

Option A: PJP diagnosis or use for prevention AND TMP‑SMX intolerance/hypersensitivity or FDA contraindication
Option B: CMS compendia‑supported indication

Prior Authorization

Attruby PA: diagnostic confirmation, testing, intended use, and no combination use

Attruby requires prior authorization; initial approval requires ALL: confirmed diagnosis of ATTR‑CM with confirmatory testing (e.g., PYP scan, monoclonal antibody studies, biopsy, scintigraphy, genetic testing), intended use to reduce cardiovascular death/hospitalization, NYHA Class I–III, clinical manifestations of cardiomyopathy, and no concomitant use with Amvuttra or a tafamidis agent. Prescriber should be a specialist or have consulted one.

Confirmatory testing required (PYP scan, biopsy, monoclonal antibody studies, genetic testing) [[87]]
Prescriber is specialist or consulted specialist [[88]]
Must not be used with Amvuttra or a tafamidis agent

Prior Authorization

Austedo PA: documentation for Huntington's chorea or tardive dyskinesia and safety screening

Austedo (including Austedo XR and titration kit) requires prior authorization with documentation meeting diagnostic and safety criteria: either chorea of Huntington's disease with depression/suicide screening rules OR tardive dyskinesia with prior dose reduction/discontinuation of offending agents or rationale; and the agent must NOT be used with an MAOI or reserpine.

Chorea due to Huntington's disease pathway includes depression and suicidal ideation screening/management [[93]]
Tardive dyskinesia pathway requires prior dose reduction/discontinuation of causative agents or rationale
Must not be used with MAOI or reserpine

Prior Authorization

Tadalafil (BPH) PA: BPH diagnosis + trial of two alpha blockers

Tadalafil 2.5 mg and 5 mg for BPH require prior authorization; member must have a diagnosis of BPH AND have tried two different alpha‑blocker agents with insufficient response, intolerance, or contraindication prior to approval.

Diagnosis of BPH
Trial and inadequate response, intolerance, or contraindication to TWO alpha blockers (e.g., terazosin, doxazosin, tamsulosin)

Prior Authorization

Benlysta SC PA: active SLE/LN + continuation of standard therapy; no concurrent biologics

Benlysta SC requires prior authorization for active SLE or active lupus nephritis with continuation of standard SLE/LN therapy in combination with Benlysta, prohibition of concurrent biologic agents, and (for these indications) patient age ≥ 5 years. Renewal requires prior approval and clinical benefit.

Continue standard SLE/LN therapy in combination with Benlysta [[103]]
Do not use concurrently with another biologic agent [[103]]
Age ≥5 years for these indications [[104]]

Prior Authorization

Clobazam PA: age exemption (<65) and approval documentation requirements

Clobazam PA does not apply to patients less than 65 years of age. For applicable patients, approval requires evidence of current treatment within the past 180 days or prescriber attestation AND an FDA‑labeled indication or a CMS compendia‑supported indication; alternatively, diagnosis‑based pathways apply if no contraindications exist.

PA exemption for patients <65 years [[109]]
Evidence of claim within past 180 days or prescriber attestation plus FDA/compendia indication required when PA applies [[109]]

Prior Authorization

Benzodiazepine PA applies to patients 65+ (age-based exemption)

Benzodiazepine prior authorization applies to patients aged 65 and older for the listed benzodiazepines unless the request meets an exempt pathway (per agent). Providers must supply the required evidence or diagnosis pathways when PA applies.

PA does NOT apply to patients <65 years for these benzodiazepines [[111],[114],[121],[127]]

Note

PA age exemption: no PA for patients <65 where stated

Where the policy states a PA does not apply to patients <65, providers should not submit PA for those patients; when PA does apply, follow the group criteria.

Prior Authorization

Actemra PA: Biologic immunomodulator initial and renewal criteria

Actemra (tocilizumab) requires prior authorization under the Biologic Immunomodulators group. Initial approval requires an FDA‑labeled indication plus one supporting condition (e.g., evidence of current treatment within past 90 days, prescriber attestation with justification, prior preferred‑agent pathways) and no concomitant biologic immunomodulator use; renewal requires prior approval, continued FDA indication, clinical improvement, and no combination biologic use.

Evidence of claim within past 90 days OR prescriber attestation with clinical justification OR preferred‑agent pathway required for initial approval [[144]]
No concomitant biologic immunomodulator use for initial and renewal approvals [[144]]
Renewal requires clinical improvement [[144]]

Prior Authorization

PA required for Biologic Immunomodulators (class-level)

Prior authorization is required for biologic immunomodulator agents under the plan's PA groups; initial and renewal criteria described for the class apply to specified agents and formulations.

Follow initial and renewal class criteria: FDA indication + supporting evidence/prerequisite + no concomitant biologic use [[144],[151]]

Prior Authorization

Cosentyx PA: follow biologic immunomodulator criteria

Cosentyx (including device formulations) is covered under the Biologic Immunomodulators PA group; providers must follow the group's listed initial and renewal criteria (FDA indication + one supporting condition and no concomitant biologic use).

Prior Authorization

Enbrel PA: follow biologic immunomodulator criteria

Enbrel (including device formulations) is covered under the Biologic Immunomodulators PA group; follow the group's initial and renewal criteria including evidence of indication/supporting item and prohibition of combination biologic use.

Prior Authorization

Agent‑specific biologic PA groups (Hadlima, Orencia, Pyzchiva)

Prior authorization must be obtained through the plan's agent‑specific Biologic Immunomodulators PA groups for agents such as Hadlima, Orencia, and Pyzchiva; follow the agent entry criteria.

Hadlima PA criteria require FDA indication plus one supporting condition and no concomitant biologic use [[168]]

Prior Authorization

Drugs requiring PA: Hadlima, Orencia, Pyzchiva (examples)

The drugs covered by these PA groups include Hadlima (including Pushtouch), Orencia (including Clickject), and Pyzchiva; providers must request PA per each agent's PA group entry.

Prior Authorization

PA group requirement: Rinvoq Solution, Rinvoq Tablet, Selarsdi

Prior authorization is required for Rinvoq Solution, Rinvoq Tablet, and Selarsdi under the Biologic Immunomodulators PA groups; initial and renewal criteria of the class apply.

Prior Authorization

Initial and renewal PA criteria for biologic immunomodulators

Initial and renewal approvals for biologic immunomodulators require meeting the listed criteria: initial requires an FDA‑labeled indication and one supporting item (e.g., evidence of current treatment within lookback period or preferred/prerequisite agent pathways); renewal requires prior approval, continued FDA indication, documented clinical improvement, and no concomitant biologic immunomodulator use.

Initial: FDA indication + one supporting condition (e.g., claim within 90 days, prescriber attestation, prior preferred/conventional agent use) [[144],[150]]
Renewal: prior approval, FDA indication, clinical improvement, and no combination biologic use [[144]]

Prior Authorization

Selarsdi, Simlandi, Skyrizi PA group requirement

Selarsdi, Simlandi, and Skyrizi are subject to prior authorization under the Biologic Immunomodulators PA groups; follow the group's initial and renewal requirements including no concomitant biologic immunomodulator use.

Documentation Required

Initial/renewal documentation and evidence requirements (one supporting item required)

Initial approval requires an FDA‑labeled indication PLUS one of: evidence of a recent claim showing current treatment within the specified lookback period, prescriber attestation of current treatment, prior biologic use for the same indication, diagnosis not requiring conventional prerequisites, prior use of one formulary conventional prerequisite agent, intolerance to a conventional agent, or an FDA‑labeled contraindication to a conventional agent; renewal requires prior approval, continued FDA indication, clinical improvement, and no concurrent biologic use.

Prior Authorization

Tyenne biologic immunomodulator PA requirements

Tyenne and similar biologic immunomodulators require prior authorization; initial approval requires an FDA‑labeled indication plus evidence of current treatment or one of the preferred/prerequisite pathways, and renewal requires prior approval, FDA indication, clinical improvement, and no combination biologic use.

Prior Authorization

Chorionic Gonadotropin PA: specific eligible diagnoses and lab thresholds

Chorionic gonadotropin requires prior authorization; approval is granted when the patient meets one of the specified diagnoses (prepubertal cryptorchidism not due to anatomic obstruction; male hypogonadotropic hypogonadism with required testosterone and LH/FSH lab thresholds; or a CMS compendia‑supported indication).

Male hypogonadotropic hypogonadism requires low testosterone (<300 ng/dL or below lab lower limit) and LH/FSH low‑normal or below lab range [[256]]

Prior Authorization

Cinacalcet PA: hypercalcemia/parathyroid indications and lab threshold

Cinacalcet requires prior authorization; approval criteria include hypercalcemia due to parathyroid carcinoma OR primary hyperparathyroidism with pretreatment serum calcium above the lab upper limit AND inability to undergo parathyroidectomy, OR another FDA/CMS compendia‑supported indication.

Pretreatment serum calcium above lab upper limit required for primary HPT pathway [[259]]

Prior Authorization

Cobenfy PA: evidence of treatment or baseline assessments and antipsychotic trials

Cobenfy requires prior authorization; initial approval requires an FDA‑labeled indication PLUS either evidence of a claim within the past 180 days or prescriber attestation of current treatment, or baseline assessments (liver enzymes/bilirubin and heart rate) plus trial/failure or intolerance to TWO antipsychotics (or FDA contraindication to two antipsychotics). Renewal requires evidence of benefit and required monitoring.

Initial options include recent claim evidence, prescriber attestation, or baseline labs plus trials/intolerances to two antipsychotics [[264]]
Renewal requires evidence of ongoing treatment or monitoring and clinical benefit [[266]]

Prior Authorization

Granix PA: prescriber specialist requirement or consult

Granix requires prior authorization; approval requires an FDA‑labeled indication or CMS compendia‑supported indication AND that the prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist.

Prescriber specialty or specialist consultation required [[271]]

Note

Step Therapy

Aimovig step restriction: no combination CGRP use

Aimovig must not be used concomitantly with another CGRP agent for migraine prophylaxis; no other step therapy sequencing is specified for Aimovig in this section.

Step Therapy

Combination therapy restriction for androgens/anabolic steroids

Danazol and testosterone products must not be used in combination with another androgen or anabolic steroid unless the prescriber provides documentation supporting combination therapy.

Either no concurrent androgen/anabolic steroid use OR prescriber justification required [[46],[52]]

Step Therapy

Topical agent step: prior corticosteroid trial or documented intolerance

Eucrisa and topical tacrolimus require prior trial and inadequate response to a topical corticosteroid OR documented intolerance or contraindication to a topical corticosteroid before approval, unless a CMS compendia‑supported indication applies.

Prior inadequate response to topical corticosteroid OR intolerance/contraindication required for atopic dermatitis pathway

Step Therapy

Tadalafil (BPH) step requirement: two alpha‑blocker trials

For tadalafil for BPH, the PA requires trial and insufficient response, intolerance, or contraindication to TWO alpha blocker agents prior to approval.

Two alpha blocker trials required (or documented intolerance/contraindication) before tadalafil approval

Step Therapy

Step therapy for anxiety: trial of formulary SSRI or SNRI required

For anxiety disorder pathways in benzodiazepine group entries, documentation of trial and inadequate response to a formulary SSRI or SNRI (or documented intolerance/hypersensitivity/contraindication) is required when that pathway is used for approval.

Trial and inadequate response to formulary SSRI/SNRI (or intolerance/contraindication) is required for the anxiety diagnosis pathway

Step Therapy

Preferred biologic step: try preferred biologics first unless exception

For biologic immunomodulators, preferred biologic agents should be tried before non‑preferred agents unless the patient has intolerance, hypersensitivity, an FDA‑labeled contraindication to preferred agents, or the requested indication is not covered by preferred agents.

Preferred biologic sequencing applies per diagnosis; exceptions allowed for intolerance, hypersensitivity, contraindication, or non‑covered indication

Step Therapy

Step/prerequisite therapy varies by diagnosis — follow agent rules

Some diagnoses require trials of preferred or conventional agents prior to coverage (e.g., two preferred agents for polyarticular JIA/RA; one preferred agent for giant cell arteritis; one conventional agent for plaque psoriasis); providers must follow diagnosis‑specific prerequisite rules in the PA entry.

Two preferred agents required for polyarticular JIA and RA in specified pathways [[146]]
One conventional prerequisite required for plaque psoriasis; see formulary conventional agent list [[152],[170]]

Step Therapy

Prerequisite and preferred‑agent requirements for select diagnoses

Certain diagnoses require prior use of specified numbers of conventional or preferred TNF agents before approval (for example, ONE preferred TNF for ankylosing spondylitis, RA, adult psoriatic arthritis, and juvenile idiopathic arthritis; TWO conventional agents for moderate‑to‑severe atopic dermatitis where specified).

Step Therapy

Prerequisite agents: conventional agent required for plaque psoriasis; preferred TNF for some arthritis

For plaque psoriasis, one conventional agent (e.g., acitretin, calcipotriene, methotrexate, tazarotene, or topical corticosteroids) is required prior to biologic consideration; for some arthritis diagnoses, one preferred TNF (Hadlima or Simlandi) is required per the PA entry.

Formulary conventional agents listed for plaque psoriasis: acitretin, calcipotriene, methotrexate, tazarotene, topical corticosteroids [[152],[236]]
One preferred TNF (Hadlima or Simlandi) required for certain arthritis diagnoses [[158]]

Step Therapy

Conventional agent prerequisites: one required for plaque psoriasis; none for some conditions

Some diagnoses require one conventional prerequisite agent (for plaque psoriasis) while others require none; providers must document prior conventional therapy when required.

One conventional agent required for plaque psoriasis; no prerequisites for moderate/severe Crohn's disease, psoriatic arthritis, or moderate/severe ulcerative colitis

Step Therapy

Required prior/conventional agents: examples for plaque psoriasis

Examples of conventional agents for plaque psoriasis that may satisfy prerequisite requirements include acitretin, calcipotriene, methotrexate, tazarotene, or topical corticosteroids; include documentation of prior use when required.

Acitretin, calcipotriene, methotrexate, tazarotene, topical corticosteroids

Note

Step Therapy

Cobenfy step requirement: two antipsychotic trials unless recent treatment evidence exists

Cobenfy initial criteria include trial/failure or intolerance to TWO antipsychotics for the requested indication unless the patient is currently treated or recent claim evidence exists; providers must document trials or provide claim/attestation evidence.

Trial/failure or intolerance to two antipsychotics required unless current treatment or recent claim evidence is provided

Note

Provider must contact EmblemHealth with drug use/administration details

Providers must contact EmblemHealth to provide information describing the use and administration of the drug so coverage determination can be made.

Documentation Required

Required documentation: diagnosis and symptom frequency/severity

Providers must document the diagnosis (e.g., migraine, IBS‑D), symptom frequency/severity (e.g., ≥4 migraine days/month; severe IBS‑D features), and any required procedure/exam findings (e.g., prescriber has ruled out GI anatomic/biochemical abnormalities) when submitting a PA request.

Migraine: document ≥4 migraine headache days/month and prophylactic intent [[24]]
Alosetron: document IBS‑D severe features and GI workup [[34]]
Alcohol swabs: document insulin delivery use and insulin use within 180 days [[29]]

Documentation Required

Required clinical documentation: labs (AAT, testosterone) and dosing info

Providers must supply relevant laboratory values and dosing information where required — for example, pre‑treatment serum AAT for Prolastin‑C and pretreatment or monitoring testosterone levels for testosterone injectable approvals.

Pre‑treatment AAT level (<11 micromol/L) for Prolastin‑C [[40]]
Total/free testosterone levels per policy for testosterone injectable approvals [[52]]

Documentation Required

Attruby documentation: confirmatory testing and NYHA class required

Initial approval for Attruby requires confirmatory diagnostic testing (e.g., PYP scan, monoclonal antibody studies, biopsy, scintigraphy, or genetic testing) and documentation of NYHA class and clinical manifestations; lack of these test results may lead to denial.

Confirmatory testing examples: PYP scan, biopsy, monoclonal antibody studies, genetic testing (TTR genotyping) [[87]]
Document NYHA class I–III and cardiomyopathy manifestations

Documentation Required

Atopic dermatitis documentation: prior topical corticosteroid trial or intolerance

For atopic dermatitis agents (Eucrisa, topical tacrolimus), document the atopic dermatitis diagnosis AND either prior inadequate response to a topical corticosteroid or documented intolerance/contraindication to topical corticosteroids.

Documentation Required

Atovaquone documentation: PJP diagnosis and TMP‑SMX intolerance required

For atovaquone, providers must document the diagnosis of Pneumocystis jirovecii pneumonia or use for prevention and provide documentation of TMP‑SMX intolerance or contraindication if using the PJP pathway.

Document PJP diagnosis or prevention use and TMP‑SMX intolerance/contraindication

Documentation Required

Documentation: diagnosis‑specific supporting clinical information required

Providers must document diagnoses and supporting clinical information demonstrating fulfillment of listed criteria (e.g., chorea due to Huntington's disease or tardive dyskinesia for Austedo; prior treatment and continuation of standard therapy for Benlysta).

Documentation Required

Treatment history/attestation: claim evidence within 90–180 days or prescriber attestation required

Providers must show evidence of current treatment within the prior lookback window (90–180 days) via a claim or provide a prescriber attestation of current treatment when an evidence‑of‑treatment pathway is used for initial approval.

Evidence via claim within past 90 days (for many biologics) or 180 days (for some agents) or prescriber attestation is acceptable

Documentation Required

Initial approval documentation: FDA indication + one supporting evidence item

For initial approval of biologic immunomodulators, document the FDA‑labeled indication AND one supporting item (e.g., recent claim, prescriber attestation with justification, prior biologic/conventional agent use, intolerance/contraindication, or diagnosis exempt from prerequisites).

Choose one supporting item: claim within 90 days; prescriber attestation with justification; prior biologic use; diagnosis exempt from prerequisites; prior conventional agent use; intolerance to conventional agent; FDA contraindication to conventional agent

Documentation Required

Renewal documentation: prior approval, continued indication, clinical improvement, no combination biologic

For renewal requests, providers must document prior plan approval, continued FDA‑labeled indication, clinical improvement (slowing of disease progression or decrease in symptom severity/frequency), and that the agent is not being used in combination with another biologic immunomodulator.

Prior plan approval
Continued FDA indication
Clinical improvement documented
No concomitant biologic immunomodulator use

Note

Denial Risk

Denial risk: no PA obtained may result in non‑coverage

If the prescriber does not obtain prior authorization, the drug may not be covered.

Denial Risk

Aimovig denial triggers: diagnosis, prophylaxis use, migraine days, combination CGRP

Aimovig requests may be denied if the patient lacks a migraine diagnosis, the agent is not being used for prophylaxis, the patient has fewer than 4 migraine headache days per month, or the agent would be used with another CGRP prophylactic agent.

Migraine diagnosis and prophylactic intent required
≥4 migraine days/month required
No concurrent CGRP agent

Denial Risk

Alcohol swabs denial triggers: must be for insulin delivery + recent insulin use

Alcohol swab requests may be denied if the product is not used in delivery of insulin or the patient's medication history does not show insulin use within the past 180 days.

Denial Risk

Alosetron denial triggers: eligibility and contraindications

Alosetron may be denied if the patient does not meet IBS‑D severe criteria, is not female, fails to meet symptom‑severity requirements, or if FDA‑labeled contraindications are present.

Denial Risk

Denial risk: FDA‑labeled contraindications trigger exclusion/denial

Requests will be excluded/denied if the patient has any FDA‑labeled contraindication to the requested agent.

Denial Risk

Denial risk: missing required diagnostic or laboratory information

Requests may be denied if required diagnostic or laboratory criteria are not provided — for example, pre‑treatment AAT level for Prolastin‑C or baseline/monitoring testosterone levels for testosterone injectable approvals.

Missing AAT level (<11 micromol/L) may result in denial for Prolastin‑C [[40]]
Missing pretreatment/testosterone monitoring labs may result in denial for testosterone injectables [[52]]

Denial Risk

Armodafinil denial triggers: indication/compendia missing or combined with modafinil

Armodafinil requests may be denied if the patient does not have an FDA‑labeled indication or compendia support, or if the agent is to be used in combination with modafinil.

Do not combine with modafinil

Denial Risk

Denial risk: missing prior therapy documentation for atopic dermatitis or TMP‑SMX intolerance for atovaquone

Requests for atopic dermatitis agents or atovaquone may be denied if the required prior trial of a topical corticosteroid (for Eucrisa/tacrolimus) or documentation of TMP‑SMX intolerance (for atovaquone PJP pathway) is not provided.

Denial Risk

Attruby denial triggers: missing confirmatory testing or planned combination therapy

Attruby requests may be denied if diagnostic confirmation of ATTR‑CM (e.g., PYP scan, biopsy, genotyping) is not provided or if concomitant use with Amvuttra or a tafamidis agent is planned.

Denial Risk

Exclusion denial risk: FDA contraindications across groups

Requests will be excluded if the patient has FDA‑labeled contraindications to the requested agent; such exclusion criteria apply across multiple PA groups.

Denial Risk

Denial risk: missing treatment history or indication documentation

Requests lacking required documentation that the patient is currently being treated with the requested agent within the prior lookback window (or lacking a prescriber statement of current treatment) and lacking an FDA indication or compendia support may be denied.

Provide claim evidence within past 90–180 days or prescriber attestation when required

Note

Denial Risk

Denial risk: combination biologic immunomodulator use prohibited

Requests may be denied if the patient will be using the requested agent in combination with another biologic immunomodulator; combination biologic use is a class exclusion.

Denial Risk

Denial triggers: failure to meet initial/renewal criteria

Requests may be denied if required initial or renewal criteria are not met, including lack of FDA‑labeled indication, absence of evidence of current therapy or prerequisite agent use, or use in combination with another biologic immunomodulator.

Note

Initial Therapy Authorization Requirements (Agent-Specific)

Initial therapy criteria

Initial therapy criteria — initial approval requirements for listed agents (section header)

Initial approval requirements (header): Patient must meet agent‑specific initial approval requirements as detailed in each PA group entry (e.g., evidence of FDA indication or compendia‑supported indication, recent treatment evidence or prescriber attestation, prerequisite therapy trials or intolerance/contraindication documentation, and avoidance of concomitant excluded agents)

Lookback periods vary by agent (90–180 days); approval durations typically 12 months unless otherwise stated

Aimovig Initial Therapy

Aimovig initial: Diagnosis of migraine; agent used for migraine prophylaxis; >=4 migraine headache days per month; not used in combination with another CGRP agent4+ migraine days/month

Approval duration: 12 months

Renewal / Continuation Authorization Requirements

Step Therapy and Sequencing Requirements

Policy	Requirement
Aimovig (CGRP monoclonal antibody)
Must NOT be used concomitantly with another calcitonin gene-related peptide (CGRP) agent for migraine prophylaxis

Policy	Requirement
Androgen / Anabolic steroid agents (e.g., danazol, testosterone injectables)
Do NOT use in combination with another androgen or anabolic steroid unless the prescriber provides documentation justifying combination therapy

Policy	Requirement / Failure definition
Topical agents for atopic dermatitis (Eucrisa; topical tacrolimus)
Prior trial and inadequate response to a topical corticosteroid (or documented intolerance/hypersensitivity or FDA contraindication to topical corticosteroids) required before approval

Policy	Requirement
Tadalafil (2.5 mg, 5 mg) for benign prostatic hyperplasia (BPH)
Member must have tried TWO different alpha blocker agents and had insufficient response, intolerance/hypersensitivity, or FDA labeled contraindication prior to approval

Policy	Requirement
Anxiety disorder pathway (benzodiazepine-related approval option)
Patient must have tried and had an inadequate response to a formulary SSRI or SNRI (or have intolerance/hypersensitivity or FDA contraindication to an SSRI/SNRI) before meeting this approval pathway

Policy	Requirement
Biologic immunomodulator sequencing (preferred biologics)
Preferred biologic immunomodulator agents should be tried before non-preferred agents unless patient has intolerance, hypersensitivity, an FDA labeled contraindication to preferred agents, or the requested indication is not covered by preferred agents

Policy	Requirement / Example
Diagnosis-specific sequencing for biologics (e.g., polyarticular JIA, RA)
Some diagnoses require trials of preferred or conventional agents prior to coverage: e.g., TWO preferred agents for polyarticular juvenile idiopathic arthritis and rheumatoid arthritis; ONE preferred agent for giant cell arteritis; ONE conventional prerequisite agent required for plaque psoriasis (see formulary lists)

Policy	Illustrative requirement
Preferred-agent sequencing examples for juvenile idiopathic arthritis-like indications
Use of TWO preferred agents (examples: Hadlima, Rinvoq tablets/solution, Simlandi) is required for polyarticular juvenile idiopathic arthritis; requirements vary by age and diagnosis as specified in the policy

Policy	Prerequisite / Requirement
TNF preferred / prerequisite requirements for certain arthritides and plaque psoriasis
Use of ONE conventional prerequisite agent is required for plaque psoriasis; for some arthritides (ankylosing spondylitis, rheumatoid arthritis, adult psoriatic arthritis, juvenile idiopathic arthritis) use of ONE preferred TNF (Hadlima or Simlandi) is required prior to non-preferred biologic approval

Policy	Requirement / Sequential use
Sequential prerequisite use before biologic approval
Certain diagnoses require sequential use of specified conventional agents or preferred TNF agents before approval of non-preferred biologics (details and agent lists provided in policy per diagnosis)

Policy	Summary
Conventional prerequisite summary (plaque psoriasis and selected GI/arthritic indications)
One conventional prerequisite agent is required for plaque psoriasis (examples listed: acitretin, calcipotriene, methotrexate, tazarotene, topical corticosteroids); NO conventional prerequisites are required for moderate/severe Crohn's disease, psoriatic arthritis, or moderate/severe ulcerative colitis per policy

Policy	Required prior agents
Required prior use of specified preferred or conventional agents by diagnosis
Policy requires prior use of specified numbers of preferred or conventional agents (e.g., one or two preferred agents or one or two conventional agents depending on diagnosis) before approval; see diagnosis-specific sections for exact agent lists and counts

Policy	Requirement
Cobenfy (dextromethorphan-bupropion) step therapy
Initial approval requires trial and inadequate response to TWO antipsychotic agents, or documentation of intolerance/hypersensitivity or FDA contraindication to TWO antipsychotics, unless there is evidence of current treatment or a recent claim showing current treatment

Biosimilar/Preferred Biologic Requirements

Note

Policy Background and Scope

Background: this document is a Medicare prior authorization list for EmblemHealth Medicare plans. It identifies drugs that require pre‑approval and describes the clinical and documentation requirements providers must submit for coverage determinations under the plan.

Key Definitions and Term Clarifications

inv-162: Prior authorization definition

DefinitionPrior authorization: approval from the payer obtained by the prescriber before prescribing a listed drug to ensure coverage

Provider actionPrescriber must contact EmblemHealth to request PA and provide clinical and administration details

ConsequenceIf PA is not obtained, the drug may not be covered

inv-163: Migraine prophylaxis definition (>=4 migraine days/month context)

DefinitionMigraine prophylaxis: use of the agent to prevent or reduce frequency of migraine headaches; initial approval requires >=4 migraine headache days per month

Applies toAimovig PA group initial and renewal criteria

Combination restrictionNot to be used with another CGRP agent for migraine prophylaxis

inv-164: Insulin delivery use (for alcohol swabs) definition

DefinitionInsulin delivery use: alcohol swab product must be used in delivery of insulin to the body with documented insulin use within past 180 days

Approval durationApproval will be for 12 months when criteria met

Denial riskRequest may be denied if not used in insulin delivery or no insulin use in past 180 days

inv-165: Clinically evident emphysema (Prolastin‑C context)

DefinitionClinically evident emphysema: clinical diagnosis required alongside AATD for Prolastin‑C PA

Associated labPre‑treatment AAT must be <11 micromol/L to qualify

ContextUsed to document indication for Prolastin‑C

inv-166: Delayed puberty — definition (testosterone context)

DefinitionDelayed puberty: male adolescent indication for testosterone eligible for a 6‑month approval duration

Approval duration6 months for delayed puberty; 12 months for other testosterone indications

DocumentationPretreatment or monitoring testosterone levels required per policy

inv-167: ATTR-CM definition

DefinitionATTR-CM: cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis

Diagnostic confirmationDiagnosis must be confirmed by testing (e.g., PYP scan, monoclonal antibody studies, biopsy, scintigraphy, TTR genotyping)

Use caseQualifies for Attruby PA when other initial criteria (NYHA class I–III, clinical manifestations) met

inv-168: TMP/SMX definition (atovaquone context)

DefinitionTMP/SMX: trimethoprim/sulfamethoxazole, first-line therapy for Pneumocystis jirovecii pneumonia; atovaquone is alternative when TMP/SMX intolerance/contraindication present

Atovaquone pathwayApproval requires documentation of TMP/SMX intolerance/hypersensitivity or FDA contraindication when used for PCP

ContextUsed in Atovaquone PA criteria

inv-169: Chorea associated with Huntington's disease — definition (Austedo)

DefinitionChorea associated with Huntington's disease: movement disorder indication requiring screening for depression and suicidal ideation per Austedo criteria

Safety screeningIf depression present, must be treated; passive suicidal ideation must not be actively suicidal

Combination exclusionsAustedo must not be used with MAOI or reserpine

inv-170: Tardive dyskinesia definition (Austedo)

DefinitionTardive dyskinesia: diagnosis for Austedo approval where prescriber has reduced/discontinued offending dopamine-blocking agents or provided rationale

Required actionPrescriber must attempt dose reduction/discontinuation of causative agents or document why not appropriate

Combination exclusionsAustedo must not be used with MAOI or reserpine

inv-171: Formulary conventional agents (plaque psoriasis)

DefinitionFormulary conventional agents (plaque psoriasis): acitretin, calcipotriene, methotrexate, tazarotene, or topical corticosteroids

Prerequisite useOne conventional agent required prior to biologic consideration for plaque psoriasis

ContextListed as required prior therapy in biologic PA groups

inv-172: Formulary conventional agents (rheumatoid arthritis/JIA)

DefinitionFormulary conventional agents (rheumatoid arthritis/JIA): leflunomide, methotrexate, or sulfasalazine

Prerequisite useUse of conventional agent required for some biologic approvals in RA/JIA

ContextReferenced in preferred/prequisite agent rules

inv-173: Formulary conventional agents (plaque psoriasis) duplicate listing

DefinitionConventional agents for plaque psoriasis: acitretin, calcipotriene, methotrexate, tazarotene, or topical corticosteroids

RoleThese agents serve as the conventional prerequisite agents in PA criteria for plaque psoriasis

Renewal relevancePrior use may be documented in initial approval pathways

inv-174: Clinical improvement (renewal) definition

DefinitionClinical improvement (renewal): slowing of disease progression or decrease in symptom severity and/or frequency as documented by prescriber

Renewal requirementRequired for renewal of many biologic and specialty agents

DocumentationPrescriber must document clinical benefit for renewal

inv-175: Conventional agents (plaque psoriasis) list

ListConventional agents for plaque psoriasis: acitretin; calcipotriene; methotrexate; tazarotene; topical corticosteroids

UseOne must be used prior to biologic approval for plaque psoriasis in many PA groups

ContextAppears across multiple biologic immunomodulator PA criteria

inv-176: Hypogonadotropic hypogonadism definition (testosterone context)

DefinitionHypogonadotropic hypogonadism: hypogonadism secondary to pituitary deficiency; approval requires low serum testosterone and low/low-normal LH and FSH

Lab requirementsTotal or free testosterone below lab LLN or <300 ng/dL plus LH/FSH at low‑normal or below lab range

ApplicationUsed in Chorionic Gonadotropin PA criteria for male hypogonadotropic hypogonadism

Policy Summary

PayerEmblemHealth

PolicyPrior Authorization Criteria — Pharmacy & Specialty Drugs (Medicare PA List)

Policy CodePolicy N/A

Change TypeAdministrative update (no material clinical changes)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionProviders must obtain prior authorization and supply required documentation (diagnosis, supporting labs or treatment history) before prescribing listed drugs.

SourceLink

On This Page

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.